An FDA Analysis of Inspected Entities After Receiving Official Action Indicated Letters for Good Clinical Practice Violations.

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作者： Miah,Jung ^[1] ; Rachelle M,Swann ^[1] ; Michelle S,Anantha ^[1] ; Faranak,Jamali ^[2]

作者单位： Compliance Enforcement Branch, Division of Enforcement and Postmarketing Safety, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. ^[1] Compliance Enforcement Branch, Division of Enforcement and Postmarketing Safety, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. faranak.jamali@fda.hhs.gov. ^[2]

关键词 Bioresearch Monitoring (BIMO)Clinical investigator Form FDA 483 Good Clinical Practice compliance Inspection Sponsor

主题词横断面研究(Cross-Sectional Studies);人类(Humans);研究人员(Research Personnel);美国(United States);美国食品和药物管理局(United States Food and Drug Administration)

DOI 10.1007/s43441-021-00267-y

PMID 34101151

发布时间 2023-03-17

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Therapeutic innovation & regulatory science

2021年55卷5期

907-917页

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An FDA Analysis of Inspected Entities After Receiving Official Action Indicated Letters for Good Clinical Practice Violations.

Therapeutic innovation & regulatory science

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Therapeutic innovation & regulatory science

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An FDA Analysis of Inspected Entities After Receiving Official Action Indicated Letters for Good Clinical Practice Violations.

Therapeutic innovation & regulatory science

相似文献

Therapeutic innovation & regulatory science

相关期刊

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